Newborn babies are accustomed to the close, warm, secure environment of their mother's womb prior to birth. Newborns and young infants are commonly wrapped in swaddling type blankets to provide warmth and comfort, which simulates the cocoon-like state of the mother's womb. Swaddling mimics the pre-birth experience resulting in a comfortable and content newborn. Swaddling also helps settle the developing nervous system of the infant since newborns are overwhelmed by novel feelings and sensations in their nerves; swaddling places an infant's muscles and joint position sensors at rest.
Swaddling has been shown to calm babies with colic and fussiness. Swaddling especially settles the startle reflex in preventing the flailing of the infant's arms and thus helps the infant feel more secure.
In addition to providing comfort and warmth, parents and caregivers must provide protection from danger in an infant's sleep environment. This is generally achieved through safe positioning of infants so that they are prevented from getting into awkward positions and either harming themselves or waking themselves unnecessarily.
A general problem for positioning infants for sleep is the risk that a blanket or bedding will be loosened and/or re-positioned during sleep. In the case of the blanket being moved off the infant's body, there is a risk that the infant will become chilled from exposure to cold air and in the case of the blanket being moved over the infant's face, there is the risk of the infant suffocating from lack of oxygen.
Swaddling, if done properly, reduces the risk that an infant will become uncovered or that the swaddling blanket or bedding will come loose. However, swaddling alone cannot eliminate these risks. This is especially true for infants that are more than six weeks old, when they are stronger and more active than newborns. Furthermore, many parents and caregivers have difficulty properly swaddling infants. To obtain a proper swaddle and to achieve the desired result, the blanket must be snug enough to immobilize the infant's arms and, to a certain degree, its legs, but loose enough that it is still comfortable.
Many parents experience difficulty with swaddling due to unfamiliarity with swaddling folds; it is difficult to effectively swaddle an infant in a rectangular or square-type blanket. If not swaddled correctly, the infant often wriggles free of the swaddle, resulting in the arms being freed and vitiating the desired effect. An infant wriggling free of the swaddling blanket also is exposed to a serious risk of suffocation or SIDS related issues due to loose bedding and unrestricted positioning of the infant. Even when swaddled correctly, infants can potentially roll, becoming entrapped in the swaddling blanket or trapped faced down while still wrapped in the blanket.
The difficulties with current swaddling blankets, sleep garments, and sleep safety devices include: a propensity to come undone and become loose in the crib, putting the infant at risk of suffocation; difficulty of proper and effective application; and an inability to prevent the infant from rolling into a prone position, thus potentially becoming trapped face down in the blanket creating a serious safety issue.
Other available swaddling implements on their own may be sufficient to swaddle and position an infant during the six week post-partum stage when the infant lacks the strength and developmental capacity to roll or break free. However, after the newborn stage and still within the period of time an infant is at risk for SIDS and/or other sleep-related hazards, many implements do not properly restrain the infant's arms, do not stay on the infant's body, and do not prevent the infant from rolling into a face-down position.
In light of recent research on SIDS, it is recommended babies be placed on their backs for sleeping for as long as the infant will tolerate this position during the infant's first year. Unfortunately, presently available infant positioning implements have difficulties related to functionality and safety. Examples include, but are not limited to, positioning wedges, foam apparatus and rolled pieces of fabric.
U.S. Pat. No. 3,845,513 discloses a fitted sleeping sac that is attached to a sheet. The arms of the infant are not restrained, thereby allowing the infant to move freely and to escape the sleeping sac. Furthermore, the sheet is simply a fitted sheet with a band that passes around the mattress, which is likely to be shifted by the movements of the infant, thereby exposing it to risk of injury.
U.S. Pat. No. 6,009,576 discloses a body conforming blanket that forms a pouch by using flaps that are wrapped and secured by using a hook and loop fastening system. With this design, the infant is not prevented from rolling over or from wriggling free or kicking its way out of the blanket.
U.S. Pat. No. 6,301,729 discloses a pocket type bedding device that secures an infant between a sheet and the mattress cover. It does not restrain the infant's movements, the infant is not prevented from rolling over, and the infant can escape as easily as from regular bed sheet or blanket.
U.S. Pat. No. 6,631,528 discloses a crib sheet with a blanket sewn on it to wrap around the infant to retain the infant in a supine position. This device does not swaddle the infant, rather, it simply wraps around the baby's torso leaving the arms and shoulders free. Because the infant's arms remain free, this design allows a baby a great deal of mobility. In practice, an infant is still able roll onto its stomach within the apparatus, exposing the infant to a risk for SIDS and suffocation. In addition, since the crib sheet is fastened about the mattress, it is likely to be shifted by the movement of the infant, thereby potentially loosening bedding and bringing the infant closer to the edge of the bed/crib.
U.S. Pat. No. 6,817,048 discloses an infant restraining device with a bottom sheet tied to a mattress with ropes or ties and a sleep pouch attached to the bottom sheet by a material pivot and with a piece of hook and loop material. It is suggested in the '048 patent that the material pivot allows the infant to move, without allowing it to rollover. However, in practice, it is unnecessary and simply increases the risk that the baby will rollover and/or become entangled. Furthermore, the device of the '048 patent leaves the infants arms free, which significantly increases the risk that the infant will be able to escape. In particular, the device has Velcro™ shoulder straps that are fastened on the front of the infant within easy reach of the infant's hands. The infant can, therefore, easily undo the straps with its hands, effectively defeating the purpose of the device. In addition, having long, thin straps so close to a child's neck presents an unnecessary hazard. These straps pose a risk of chafing and/or strangulation if they were to come undone.
The apparatus of the '048 patent uses a bottom sheet that is a “half-sheet mattress cover” attached to a mattress with straps going underneath to the other side. The infant's movement can cause the entire blanket, device and infant to shift over to the edge of the bed, thereby defeating the purpose of the device.
Thus, there remains a need in the art for an infant bedding product which functions to restrain an infant's movements, keeps an infant warm, prevents the infant from escaping, prevents an infant from moving from a supine or side-lying position to a dangerous prone position, and prevents an infant from shifting or loosening the bedding.